Cervical CancerNCT01806350
Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors
A study testing questionnaire administration, standard follow-up care and educational intervention in people with Cervical Cancer and Endometrial Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies pelvic floor muscle training in treating urinary incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help control symptoms and improve physical function and quality of life in gynecologic cancer survivors. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Ovarian Epithelial Cancer
- What is being tested?
- questionnaire administration, standard follow-up care and educational intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of uterine, cervical, ovarian or vulvar malignancy
- Treatment free interval of >= one year and currently have no evidence of cancer
- Reports urinary incontinence based on screening questionnaire
- Must have a stable address for the three month period
Who cannot join
- Current clinical evidence of urinary tract infection
- Within three months of failed surgery for urinary incontinence
- Planned surgery for urinary incontinence in the next three months
- Presence of neurologic condition that may impact bladder symptoms such as multiple sclerosis, stroke
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
About this study
Official title: A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors
This randomized pilot clinical trial studies pelvic floor muscle training in treating urinary incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help control symptoms and improve physical function and quality of life in gynecologic cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess whether pelvic floor muscle training and behavioral therapy in gynecologic cancer survivors results in improvement in incontinence symptoms as measured by a validated questionnaire (Patient Global Impression of Improvement) at three month follow-up when compared to women who do not undergo pelvic floor muscle training.
II. To evaluate whether women who undergo pelvic floor muscle training and behavioral therapy report greater improvement in validated urinary incontinence symptom severity, pelvic floor distress and quality of life measures than women who do not undergo pelvic floor muscle training.
III. To evaluate the acceptability of pelvic floor muscle training (PFMT) among gynecological cancer survivors and to provide preliminary data to inform a power analysis for a larger randomized trial.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials. Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles. Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks.
ARM II: Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
After completion of study treatment, patients are followed up at 3 months.
- Conditions
- Cervical Cancer, Endometrial Cancer, Ovarian Epithelial Cancer, Ovarian Germ Cell Tumor, Uterine Sarcoma, Vulvar Cancer
- Being tested
- questionnaire administration, standard follow-up care, educational intervention
- Keywords
- Pelvic floor muscle training; incontinence; quality of life
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Carcinoma, Ovarian Epithelial, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Ancillary studies
standard follow-up careProcedure or surgery
Receive usual care
educational interventionOther
Also called intervention, educational
Undergo PFMT
| Study group | Role | What they receive |
|---|---|---|
| Arm I (PFMT) | Experimental | Patients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials. Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles. Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks. Receives: Other: questionnaire administration; Other: educational intervention |
| Arm II (usual care) | Active comparator | Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study. Receives: Other: questionnaire administration; Procedure: standard follow-up care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the Patient Global Impression of Improvement (PGI-I) rating
Fisher's exact test will be used to test whether the chance of success is identical for the two groups (intervention vs. control).
Measured: 12 weeks
Secondary outcomes (3)
Changes in the Incontinence Severity Index (ISI) score
The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner. A two sample t-test on the within individual differences will be used. A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
Measured: Baseline to 3 months
Changes in Urinary Distress Inventory (UDI)
The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner. A two sample t-test on the within individual differences will be used. A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
Measured: Baseline to 3 months
Changes in Incontinence Impact Questionnaire (IIQ), which measures the impact of urinary incontinence on quality of life
The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner. A two sample t-test on the within individual differences will be used. A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startNov 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Teresa Rutledge, MD, Principal investigator, University of New Mexico Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806350
- Sponsor's protocol ID
- INST 0912
- Other IDs
- NCI-2012-01319
- Status last verified
- Mar 2013
- First submitted
- 5 Mar 2013
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors
- ClinicalTrials.gov ID
- NCT01806350
- Acronym / sponsor ID
- INST 0912
- Conditions
- Cervical Cancer, Endometrial Cancer, Ovarian Epithelial Cancer, Ovarian Germ Cell Tumor, Uterine Sarcoma, Vulvar Cancer
- Keywords
- Pelvic floor muscle training; incontinence; quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot clinical trial studies pelvic floor muscle training in treating urinary incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help control symptoms and improve physical function and quality of life in gynecologic cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- To assess whether pelvic floor muscle training and behavioral therapy in gynecologic cancer survivors results in improvement in incontinence symptoms as measured by a validated questionnaire (Patient Global Impression of Improvement) at three month follow-up when compared to women who do not undergo pelvic floor muscle training.
II. To evaluate whether women who undergo pelvic floor muscle training and behavioral therapy report greater improvement in validated urinary incontinence symptom severity, pelvic floor distress and quality of life measures than women who do not undergo pelvic floor muscle training.
III. To evaluate the acceptability of pelvic floor muscle training (PFMT) among gynecological cancer survivors and to provide preliminary data to inform a power analysis for a larger randomized trial.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials. Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles. Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks.
ARM II: Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
After completion of study treatment, patients are followed up at 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (PFMT) | Experimental | Other: questionnaire administration, Other: educational interventionPatients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials. Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles. Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks. |
| Arm II (usual care) | Active comparator | Other: questionnaire administration, Procedure: standard follow-up carePatients receive usual care for urinary incontinence, with an option to join the training program after completion of study. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of uterine, cervical, ovarian or vulvar malignancy
- Treatment free interval of >= one year and currently have no evidence of cancer
- Reports urinary incontinence based on screening questionnaire
- Must have a stable address for the three month period
Key exclusion criteria (5 listed)
- Current clinical evidence of urinary tract infection
- Within three months of failed surgery for urinary incontinence
- Planned surgery for urinary incontinence in the next three months
- Presence of neurologic condition that may impact bladder symptoms such as multiple sclerosis, stroke
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administrationAncillary studies | Other | Arm I (PFMT), Arm II (usual care) |
| standard follow-up careReceive usual care | Procedure or surgery | Arm II (usual care) |
| educational interventionAlso: intervention, educationalUndergo PFMT | Other | Arm I (PFMT) |
Primary outcome
Improvement in the Patient Global Impression of Improvement (PGI-I) rating
Time frame: 12 weeks
Fisher's exact test will be used to test whether the chance of success is identical for the two groups (intervention vs. control).
3 secondary outcomes
Changes in the Incontinence Severity Index (ISI) score
Time frame: Baseline to 3 months
Changes in Urinary Distress Inventory (UDI)
Time frame: Baseline to 3 months
Changes in Incontinence Impact Questionnaire (IIQ), which measures the impact of urinary incontinence on quality of life
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
- University of New Mexico Cancer CenterLink provided by the sponsor.
- New Mexico Cancer Care AllianceLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Rutledge, MD principal investigator
University of New Mexico Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, standard follow-up care and educational intervention in people with Cervical Cancer and Endometrial Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the Patient Global Impression of Improvement (PGI-I) rating (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2013.